Timing of Surgical Intervention in Buruli Ulcer Patients Treated With Antibiotics (Burulitime)

July 18, 2019 updated by: Ymkje Stienstra, University Medical Center Groningen

Timing of the Decision on Surgical Intervention for Buruli Ulcer Patients Treated With Rifampicin/Streptomycin

SUMMARY

Rationale: Buruli ulcer, caused by Mycobacterium ulcerans, is an ulcerative disease endemic in West Africa. It often leads to functional limitations. Treatment was by extensive surgery, until in 2005 gradually antibiotic treatment for eight weeks with rifampicin and streptomycin was added. Observation of Buruli ulcer lesions of limited size during antibiotic treatment showed that during treatment there is a paradoxical increase of the lesion, with a decrease of the lesion after week 14. Current WHO protocols advise to decide whether surgery is needed four weeks after the start of antibiotics. This might be too early in the healing process. The investigators hypothesize that delay in surgery is safe, and that it results in a reduction of the number of surgical interventions.

Objectives:

Primary Objective of this study is to compare the need for surgical treatment in standard timing of surgery at the end of eight weeks antimicrobial treatment with a policy to postpone surgical treatment until week 14.

Secondary Objectives are to study whether postponing surgery leads to less extensive surgery and a change in frequency of functional limitations;

Study design:

Patients will be randomized for surgery at week 8 after start of antibiotic treatment and week 14 after start of treatment. Reasons for treating doctors to decide to intervene with surgery will be according to current clinical practice and will be clearly defined in this protocol. Standard care of eight weeks of rifampicin and streptomycin will be given. All patients will be followed and lesional size using acetate sheet recordings will be used during follow-up.

Study population: Patients with a clinical picture of Buruli ulcer disease confirmed by diagnostic tests in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin. Patients who are pregnant, have a contraindication for general anaesthesia and children below three years old will be excluded. 130 Patients in each treatment arm will be included to detect a difference in percentage of patients needing surgery of 20 percent.

Main study parameters/endpoints: Primary outcome measure is the number of patients healed without surgery. Secondary outcome measures are the extent of surgery by measurement of lesional size, functional limitations after the end of treatment and one year after the start of treatment and the duration of admission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Benin
      • Allada, Benin
        • Buruli ulcer center Allada
      • Lalo, Benin
        • Buruli ulcer center Lalo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a clinical picture of Buruli ulcer disease in the districts covered by the Buruli ulcer centers in Lalo and Allada, Benin, will be included at start of antibiotic treatment.
  • All stages of the disease will be included. Only patients with confirmed disease by direct microscopy following acid-fast staining or PCR will be included.

Exclusion Criteria:

  • Patients not on the standard treatment of eight weeks of rifampicin and streptomycin for any reason, will be excluded from this study.
  • Treatment with macrolide or quinolone antibiotics, or antituberculous medication, or immune-modulatory drugs including corticosteroids within the previous one month.
  • Patients not compliant with the antibiotic therapy will be excluded as well. Non-compliance is defined as the use of < 70 % of the prescribed antibiotics.
  • Patients with a contraindication for general anaesthesia are not able to participate.
  • Pregnancy.
  • Osteomyelitis.
  • Lesion close to the eye, with preferred standard treatment to wait for effect antibiotic treatment on extent surgery.
  • The BUFLS (Buruli ulcer functional limitation score) cannot be applied to children below three years and therefore will not participate.
  • Patients reporting to refuse surgery at any point in the intended treatment, cannot be included.
  • Any situation or condition which may compromise ability to comply with the trial procedures.
  • Patients known to be HIV positive.
  • Lack of willingness to give informed consent (and/or assent by parent/legal representative).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: evaluation surgical intervention at week 8
Procedure: surgical intervention on Buruli ulcer
Can the need for surgical intervention be avoided by delay of the decision on surgical intervention, comparing the need on surgical intervention from time points of week 8 and week 14 (number of weeks after start of antibiotic treatment with streptomycin/rifampicin).
Other: evaluation surgical intervention at week 14
Procedure: surgical intervention on Buruli ulcer
Can the need for surgical intervention be avoided by delay of the decision on surgical intervention, comparing the need on surgical intervention from time points of week 8 and week 14 (number of weeks after start of antibiotic treatment with streptomycin/rifampicin).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing without surgical intervention
Time Frame: one year
measurement of lesions at follow up visit, if lesion closed-> healed.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

Laboratoire de Référence des Mycobactéries
PNLUB, Ministère de la santé, Cotonou, République du Bénin.

Investigators

  • Principal Investigator: D Agossadou, MD, Program national lutte contre la lèpre et l'ulcère de Buruli, ministère de la santé, Hospital Lalo
  • Principal Investigator: G Sopoh, MD PhD, Program national lutte contre la lèpre et l'ulcère de Buruli, Ministère de la Santé, Cotonou, Bénin, hospital Allada
  • Principal Investigator: Tjip S van der Werf, MD PhD, UMCG - internal medicine/infectious diseases
  • Principal Investigator: R OC Johnson, MD PhD, Cotonou, Bénin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

September 8, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (Estimate)

September 13, 2011

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BURULIVENI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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